Experimental Biomarker Study for Pain Thresholds

Pain Clinical Trial

Official title:

Randomized, Double Blind, Positive- Controlled, Three-way Cross-over Human Experimental Biomarker Study of V116517 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02695745
• Other study ID #: VND1004
• Secondary ID: 2011-002399-18
• Status: Completed
• Phase: Phase 1
• First received: February 22, 2016
• Last updated: February 24, 2016
• Start date: September 2011
• Est. completion date: January 2012

Study information

• Verified date: February 2016
• Source: Purdue Pharma LP
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to characterize the heat pain tolerance threshold (HPTolTr) in primary hyperalgesic skin after topical capsaicin application, and to assess heat pain and mechanical thresholds (eg, pressure pain, stimulus-response) following skin sensitization by UVB (ultraviolet B) irradiation and topical capsaicin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria include:

1. Signed informed consent obtained.

2. Males aged 18 to 45, inclusive.

3. Body weight ranging from 50 to 100 kg and BMI ranging from 18 to 32 (kg/m2), inclusive.

4. Healthy and free of significant abnormal findings as determined by medical history, physical examination, clinical laboratory values, vital signs, and ECG.

Exclusion Criteria include:

1. Current or recent (within 5 years) history of drug or alcohol abuse.

2. History or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion.

3. Any history of frequent nausea or emesis regardless of etiology.

4. Any history of allergic-type reactions to sulfonamides, or any experience of asthma, urticarial, or other allergic-type reactions after taking aspirin or other NSAIDS.

5. Subjects who do not develop erythema at the maximum dose of the UVB source (MED determination for UVB model) will be excluded from the study.

Other protocol-specific inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• V116517 aqueous suspension
300 mg (approximately 100 mL) aqueous suspension taken orally x 1 dose
• Celecoxib capsules
400 mg (2 capsules of 200 mg each) taken orally x 1 dose
• Placebo
Placebo for V116517 aqueous suspension taken orally x 1 dose and/or placebo for celecoxib, 2 capsules taken orally x 1 dose
• Capsaicin
1% administered topically

Locations

Country	Name	City	State
Denmark	CCBR A/S	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Purdue Pharma LP

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heat pain tolerance threshold (HPTolTr) in primary hyperalgesic skin after topical capsaicin application	Mean temperature in degrees Celsius (°C) based on the difference (post-dose and pre-dose) of the differences between the capsaicin at the control arm and the treated arm	3.5 hours post-dose	No
Secondary	Heat Pain Threshold (HPTr)	Mean temperature in degrees Celsius (°C)	3.5 hours post-dose	No
Secondary	Heat Pain tolerance threshold (HPTolTr)	Mean temperature in degrees Celsius (°C)	Pre-dose and 3.5 hours post-dose	No
Secondary	Pressure Pain Threshold (PPTr)	Mean pressure kPA	3.5 hours post-dose	No
Secondary	Pressure Pain tolerance threshold (PPTolTr)	Mean pressure kPA	3.5 hours post-dose	No
Secondary	Peripheral nociceptor activation using Laser Doppler flowmetry	Peripheral nociceptor activation will be assessed by monitoring cutaneous blood flow using Laser Doppler imaging	3.5 hours post-dose	No
Secondary	Erythema at the treated area using Erythema index	Erythema at the treated area will be assessed using colorimetry	3.5 hours post-dose	No
Secondary	Stimulus-response function to graded von Frey hair stimulation	The mean pain intensity of the stimulations on a '0-10' visual analog scale (VAS), where '0' indicates ''no pain" and '10' indicates '' the most intense pain imaginable''	3.5 hours post-dose	No
Secondary	Secondary pin-prick hyperalgesic area	The area will be assessed using a 60 g weighted von Frey hair, and subjects are asked to report when the sensation changes to a "different sensation", "unpleasant" or "burning pain" sensation	3.5 hours post-dose	No
Secondary	Evaluation of change in body temperature	Oral temperature in degrees Celsius (°C)	Pre-dose and up to 72 hours post-dose	No